Radiotherapy vs Observation for CRPC

• Conditions: Hormone Refractory Prostate Cancer

• Registration Number: NCT01590498
• Lead Sponsor: Zhengzhou University

Brief Summary

The purpose of the study is to determine whether radiotherapy improves cancer control and overall survival among patients with Castration resistant prostate cancer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-27
• Status Verified: 2012-05
• Study Start: 2012-05
• Study First Submitted QC: 2012-05-01
• Study First Posted: 2012-05-03
• Last Update Submitted: 2012-05-03
• Last Update Posted: 2012-05-04
• Primary Completion: 2016-12
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 2000

Inclusion Criteria

1. Eligible patients had histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiologic evidence of disease progression during hormonal therapy
2. Patients were receiving primary androgen-ablation therapy as maintenance therapy. At least four weeks had to have elapsed between the withdrawal of antiandrogens (six weeks in the case of bicalutamide) and enroll ment, so as to avoid the possibility of confounding as a result of the response to antiandrogen withdrawal.
3. Another requirement was disease progression, as indicated by increasing serum levels of PSA on three consecutive measurements obtained at least one week apart or findings on physical examination or imaging studies.
4. Normal cardiac function was required.

Exclusion Criteria

1. patients had a Karnofsky performance-status score of at most 60 percent
2. prior treatment with cytotoxic agents or radioisotopes
3. with history of another cancer within the preceding five years, brain or leptomeningeal metastases, symptomatic peripheral neuropathy of grade 2 or higher, and other serious medical condition.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
overall survival	From the date of biochemical or clinical recurrence of prostate cancer following hormonal therapy to December 31, 2016 or date of death from any cause, whichever came first, assessed up to 3 years.

Secondary Outcome Measures

Name	Time	Method
prostate cancer specific mortality	From the date of biochemical or clinical recurrence of prostate cancer following hormonal therapy to December 31, 2016 or death from prostate cancer or treatment complications, whichever came first, assessed up to 3 years.

Trial Locations

Locations (1)

the first affiliated hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China